From Clinical Trials to the Front Line: Vinflunine for Treatment of Urothelial Cell Carcinoma at the National Cancer Institute of Naples
| Autor: | GAETANO eFACCHINI, Chiara eDella Pepa, Carla eCavaliere, Sabrina Chiara Cecere, Marilena eDi Napoli, Carmine eD'Aniello, Anna eCrispo, Gelsomina eIovane, Piera eMaiolino, Teresa eTramontano, Raffaele ePiscitelli, Salvatore ePisconti, Lino eDel Pup, Maurizio eMontella, Massimiliano eBerretta, Domenico eSorrentino, Sisto ePerdonà, Sandro ePignata |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty response rate medicine.medical_treatment overall survival law.invention transitional cell cancer of the urothelial tract 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine Medicine Pharmacology (medical) Progression-free survival Original Research Pharmacology Chemotherapy progression free survival Vinflunine business.industry lcsh:RM1-950 Cancer Retrospective cohort study medicine.disease Surgery Clinical trial lcsh:Therapeutics. Pharmacology 030104 developmental biology chemistry 030220 oncology & carcinogenesis Observational study business vinflunine Overall survival Progression free survival Response rate Transitional cell cancer of the urothelial tract |
| Zdroj: | Frontiers in Pharmacology Frontiers in Pharmacology, Vol 7 (2016) |
| ISSN: | 1663-9812 |
| Popis: | Background: The efficacy of Vinflunine, after failure of platinum-based chemotherapy in patients with metastatic or recurrent Transitional Cell Cancer of the Urothelial Tract, TCCU, has been demonstrated in an international, randomized, phase III trial comparing Vinflunine plus Best Supportive Care, BSC, with BSC alone. On the basis of that study vinflunine has been approved by the European Medicine Association, EMA, for treatment of TCCU patients after failure of a platinum treatment. However, since data in clinical trials often differ from routine clinical practice due to unselected population and less strict monitoring, “real life” experiences are very helpful to verify the efficacy of a new therapy. Methods: This was a spontaneous, observational, retrospective study involving 43 patients with metastatic TCCU treated with vinflunine at our cancer center, data about demographics, disease characteristics, and previous treatments were collected and outcome and toxicities of vinflunine were analyzed. Results: 41 of 43 patients were eligible for RR analysis, the Overall RR was 12%, the Disease Control Rate was 29%; when including only patients treated in II line the DCR rose to 33%; the median PFS and the median OS were 2.2 and 6.9 months, respectively. Conclusion: Our findings were consistent with the outcome data emerged in the phase III randomized trial and in the other observational studies conducted all around Europe in the last 2–3 years. This experience supports the use of vinflunine in patients with advanced TTCU as effective and manageable antineoplastic drug. |
| Databáze: | OpenAIRE |
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